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Florida Gulf Coast University Digital Hospital and Medical Information System

Computer Information Systems Program College of Business Florida Gulf Coast University

Team agle!

Joe Ciliberti

[email protected]

Eugene Hoyt

[email protected]  [email protected] 

Bill Mack

[email protected]

Jamie ewis

 [email protected]"u   [email protected]"u 

 

 

Pro"ect Mentor

Janus# $alewski% &h.'.

[email protected]"u  [email protected]"u 

 

Ta#le of Contents $% Introduction $%$ Purpose $%& Scope of Document $%' Definitions( )cronyms( and )##reviations $%* +eferences $%, -vervie. of document &% Description of Pro"ect &%$ Pro"ect -vervie. &%& Pro"ect Functions &%' User C/aracteristics &%* Constraints to Pro"ect Development and Implementation &%, )ssumptions and Dependencies '% Specific +e0uirements of P/ysician -ffice System '%$ Functional +e0uirements of P/ysician Digital +ecord System '%& 1on2 Functiona Functionall +e0uirements of P/ysician Digital +ecord System '%' P/ysician Digital +ecord System Performance '%* 3ogical Data#ase +e0uirements '%, Design Constraints

 

*% Specific +e0uirements of Hospital System *%$ Functional +e0uirements of Hospital Digital +ecord System *%& 1on2 Functional +e0uirements of Hospital Digital +ecord System *%' Hospital Digital +ecord System Performa Performance nce *%* 3ogical Data#ase +e0uirements *%, Design Constraints ,% Specific +e0uirements of +eal2time Patient Monitoring System ,%$ Functional +e0uirements of +eal2time Patient Monitoring System ,%& 1on2 Functional +e0uirements of +eal2time Patient Monitoring System ,%' +eal2time Patient Monitoring System Performance ,%* Design Constraints 4% Specific +e0uirements of )m#ulatory Medical System 4%$ Functio Functional nal +e0u +e0uire iremen ments ts of )m )m#ula #ulatory tory Med Medical ical Syste System m 4%& 1on2 Functional +e0uirements of )m#ulatory Medical System 4%' +eal2time )m#ulatory Medical System Performance 4%* Design Constraints

 

$% Introduction Introduction $%$ Purpose   (he software re)uirement specification "ocument is specifically "esigne" to "elineate the boun"aries of the Healthcare *nformation +ystem "esign an" functionality. &arties &arties intereste" in this "ocumentation woul" inclu"e but not  be limite" to the system owners% the system users% the the pro!ect manager an" the "esign team.

$%& Scope of Document (his "ocument will i"entify the pertinent software pro"ucts we will "e,elop inclu"ing a Host 'BM+% J-J-- software supporte" an" web/base" &atient% &hysician% an" -mbulatory *nput0utputs% an" sensor "ri,en inputs for real/time patient monitoring. (he +2+ will show that we will be utili#ing +3 ser,er an" -+& for interfacing with the *nput0utputs as well as Ja,a applets for the real/time ac)uisition of health "ata from remote sources. 4inally% utili#ing utili#ing the security attributes of 5M% 5+% an" a secure socket layer in the protocol stack we hope h ope to a""ress the ,ali" security concerns about the networking an" transmission of confi"ential health care information. *n a""ition to the specific "esign components of this software% this "ocument will make clear the "esign team6s goals of creating ,alue/a""e" software which not only correctly captures patient health information% but then efficiently stores it% sorts it% retrie,es it% an" "eli,ers this critical care information where it is nee"e" by healthcare professionals. (he benefit of ha,ing accurate% complete% an" timely health information is that it will ine,itably sa,e human li,es. (his software is "eliberately focuse" on me"ical recor"s an" the associate" "iagnostics. *t is important to point out that this system which is life critical will not ha,e cross functionality regar"ing appointment

 

management% billing% or insurance functions% howe,er "iagnostic co"es sets will be compliant with present 4e"eral law.

$%' Definitions( )cronyms( and )##reviations $%'%$ Electro/car"iogram 7E89:. - "e,ice that measures the electrical acti,ity in a biological heart an" measures heart rate. $%'%& &ulse oximeter. - "e,ice that employs monochromatic light to measures percentages of oxygenate" hemoglobin in bloo". $%'%' +ystolic bloo" pressure. (he peak pressure in the arterial circulatory system. $%'%* 'iastolic bloo" pressure. (he pressure at which the heart6s aortic aortic ,al,e closes. $%'%, Emergency me"ical technician 7EM(:. - traine" emergency healthcare

specialist. $%'%4 scilloscope monitor. - catho"e ray tube capable of representing a  beam of light that simulates a heart rhythm wa,eform. $%'%5 7H*&7H*&--: -: /(he Health *nsurance &ortability & ortability an" -ccountability -ct of 1;;< $%'%6 7+'C:/(he +ystems 'e,elopment ife Cycle. $%'%7 =on/'igiti#e" &rofessionals. Health Care pro,i"ers who ha,e no access to "igital recor"s through lack of har"ware% h ar"ware% software% or  preference to legacy flat file charting metho"s. $%'%$8 7-E+:2-",ance" Encryption +tan"ar" $%'%$$ 7'+&: /'istribute" +er,ices &ro,i"er  $%'%$& 7-+&: >-pplication +er,ice &ro,i"er $%'%$' 74-(?: / 4ile -llocation (able ? Bit $%'%$* 7(*44: > (ag *mage 4ile 4ormat $%'%$, 7J&E9: / Joint &hotographic Experts 9roup $%'%$4 7'B: > 'ate of Birth

 

$%'%$5 e en"or. n"or. - license" an" authori#e" agent of the "e,elopment team or their ,este" remain"ermen. $%'%$6 *+ A<1. - stan"ar" format for representing "ate an" time recommen"e" by the *nternational rgani#ation for for +tan"ar"i#ation $%'%$7 *nitial patient information. *nformation normally gathere" "uring a  patient6s first arri,al in a healthcare pro,i"er6s office or in an emergency room. (his inclu"es but not limite" to name% a""ress% +ocial +ecurity =umber an" any health insurance numbers. $%'%&8 7fps: > 4rames per secon" $%'%&$ 7C*+'C: > Computer *nformation +ociety 'esign Competition

$%* +eferences 1D Mack% 4rancis E. M'% &ersonal *nter,iew 4ebruary 1% ?   D+un"aram% +enthilnathan% Requirements +enthilnathan% Requirements Analysis Analysis of Software Requirements  for Telemedicine Telemedicine and the HealthCare Industry% Industry% Master (hesis% C4% rlan"o% 4lori"a% July 1;% 

$%, -vervie. of document (he +oftware 2e)uirement +pecification will "efine an" illustrate the o,erall pro!ect an" its re)uirem re)uirements/ ents/ both functional an" non/functional. *n a""ition the +2+ will "efine the users an" their respecti,e characteristics as well as any constraints to "e,elopment that the team has i"entifie". (he format of the +2+ "ocument will a""ress the o,erall pro!ect first/ inclu"ing functions an" ob!ecti,es in an o,er,iew. ( (his his section will also a""ress how this software interfaces with other legacy systems an"0or "iagnostic e)uipment connecte" to it. (hen the subse)uent sections will specifically a""resses the components of the larger software system. (hese sections "elineate specifications for e,ery facet of the components "esign.

&% Description of Pro"ect

 

&%$ Pro"ect -vervie. Me"ical recor"s are the keystone to the healthcare professionF howe,er these recor"s are not utili#e" to their fullest potential. ften recor"s are inaccurate% misplace"% an" 0or "uplicate" unnecessarily. *n a worl" which recogni#es the impro,ement of "ata "igiti#ation an" networking as a constructi,e force which often increases efficiency while lowering costsF it is our ,iew that me"ical recor"s networking coul" only benefit the )uality of healthcare offere" in the nite" +tates. -n information system which is primarily linke" between a physician6s office an" his hospital woul" be able to capture an" store "ata from either location gi,ing access to "iagnostics from satellite locations. -""e" functionality coul" inclu"e ability to gather "ata in real time from a remote monitor or an inboun" Emergency transport ,ehicle. D (his information system is an in"ustry/compliant application% base" upon an open architecture 7Microsoft =(0+3 relational "atabase:% an" is "esigne" to function within a stan"ar" *EEE compliant Ethernet 71 or 1: ocal or Gi"e -rea =etwork en,ironment% an" will also also inclu"e Gireless Gireless capabilities. capabilities. (he communications protocol is (C&0*&% an" is supporte" u un"er n"er any routing protocol within an infrastructure 7route" or bri"ge":. (he software is base" upon stan"ar" an" emerging web technologies% re)uiring a workstation to only be capable of running an *nternet Browser such as Microsoft6ss *nternet Explorer an" Microsoft6 a n" =etscape =a,igator. Githin Githin the browser Ja,a applets will parse an" "isplay real/time "ata in the form of streaming M&E9  ,i"eo% still images in J&E9 or (iff format% format% an" a !a,a bean real/time graph plotter from "iagnostic e)uipment anywhere within the network. -s a 'istribute" +ystems &ro,i"er 7'+&: the system offers all the a",antages of an -pplication +er,ice &ro,i"er 7-+&:% but o,ercomes security an"  proximity issues by allowing hospitals to keep the primary primary system at their facility. facility.  

&%& Pro"ect Functions

 

 

&%&%$ (he software co"e shoul" be portable between "ifferent operating systems

such as inux an" Gin"ows. &%&%&  (he software shoul" be easy to use an" shoul" re)uire minimum manual

operation. &%&%' (he software shoul" ha,e a user/familiar interface so that the system

woul" not pose an a""itional workloa" to the users.  =ote. *nterface "esign woul" follow generally accepte" mo"el con,entions for placement of "rop"own menus an" toolbars. &%&%* (he software shoul" allow bi"irectional synchronous communication

 between the user an" the "ata source in real time. &%&%, (he software shoul" pro,i"e security of operation an" confi"entiality of

information 7restricting access to non/pri,ilege" users:% by 4-( 4-(? compression of "ata an" 2i!n"ael 7-E+: encryption algorithms. &%&%4 (he software shoul" allow collection of ,ital signs an" still images of the  patient for ,isual inspection by experts.  

&%&%5 (he software shoul" ha,e tools for computer assiste" "iagnosis like an

electronic stethoscope% a bloo" oxygen sensor% E89% an" a "igital sphygmomanometer.  

&%&%6 (he software shoul" be able to a,oi" congestion while transmitting high

,olumes of "ata an" images in real/time.  

&%&%7 (he software shoul" sample ,i"eo images from "iagnostic e)uipment

automatically at ?fps or rates compatible with the transmission capacity a,ailable.  

&%&%$8 (he software shoul" be able to interface an" link all components of

system refer to 4igure ..1

 

4igure ..1 Context 'iagram   office% &%&%$$ (he system will exten" the "ata capabilities of the &hysician6s office% the hospital% an" emergency personnel. 2efer to 4igure ..

 

Figure &%&%& Use Cases

 

 &%' User C/aracteristics   &%'%$ (he primary user will be a healthcare professional like a physician% a nurse% or an emergency me"ical technician.  =ote. (his is a Me"ical *nformation *nformation +ystem therefore to limit access an" ensure integrity of the "ata only license" me"ical personnel ha,e access to input% search% an" up"ate functions.  

&%'%& =urse -"ministrators% -"ministrators% &hysician ffice ffice -"ministrators% -"ministrators% +ystem

-"ministrators an"0or (herapists will ha,e limite" access an" an " information capabilities.  =oteI 4or the reasons clearly state" in .?.1 the +ystem -"ministrator -"ministrator 7or

 

en"or: e n"or: will only be able to access "ata with his -"min access co"e in combination with the &hysician6s & hysician6s co"e while in the physician6s presence.

&%* Constraints to Pro"ect Development and Implementation   &%*%$ (he Health *nsurance &ortability an" -ccountability -ct ct of 1;;<

7H*&--: 7H*&-: has man"ate" ,arious stan"ar"s on security security%% pri,acy% transaction an" co"e sets% an" uni)ue healthcare i"entifiers to which this system must a"here. &%*%& egacy systems in place must be consi"ere" an" mo"ifie" to interface

with the new system "esign. &%*%' (he timebox which encapsulates the +'C may limit some functionality of the system. &%*%* Both the hospital an" physician "atabase will nee" large storage

capabilities an" a process to archi,e out"ate" "ata.  

7=ote. Metho" an" si#e of 'atabase storage (B':

&%*%, &aper flat file me"ical recor"s will nee" to be pro"uce" an" store" to

ensure ability to han"le non/"igiti#e" me"ical professionals.  

 

&%, )ssumptions and Dependencies   &%,%$ (he system relies on a &hysician relationship with a hospital system with

which he0she is a staff member. &%,%& (he +'C chosen to implement the system will be mo"el "ri,en an"

 base" on subse)uent ,ersions to insure "ata integrity an" functionality. functionality. 2efer to figure ..1   &%,%' 'ue to report length constraints impose" by C*+'C% H*&-- regulations

will be strictly followe" but kept as a stan" alone "ocument.

Model Driven System Development 3ife Cycle

 

 

Figure &%,%$ Model Driven Hy#rid SD3C

'% Specific +e0uirements of P/ysician -ffice System

 

'%$ Functional +e0uirements of P/ysician Digital +ecord System   '%$%$ (he software must allow input of patient "ata from patient 7initial: home%

secure" access at &hysician an" =urse Gorkstations% Gorkstations% an" from the "ata streaming real/time monitoring e)uipment.  

=ote. - web/base" system can allow initial patient information to be gathere" by a "umb terminal in office or from patient6s own computer upon Email appointment ,erification hyperlinke" to a web/base" input screen. '%$%& (he software must re)uest username an" passwor" for access to "ata% " ata% only

after authentication will allow access to the system. '%$%' (he software must re)uire high le,els of error correction an" input

,ali"ation.  =ote. Message box prompts woul" re)uire a secon" entry of key "ata fiel"s inclu"ing name% 'B% +ocial +ecurity =umber% me"ications an" allergies. 'octor6s inputs will similarly prompt proper co"e sets for "iagnosis. '%$%* (he software must allow browsing by the physician of historical me"ical

information of his0her patients only. '%$%, (he software must i"entify the patient by a uni)ue numeric i"entifier

"eri,e" from a function performe" on the patient6s birth "ate.  =ote. -lgorithm -lgorithm will be simply ('-K ('-K/B* /B*2( 2(H'-K H'-K L =M 'octor key  *ncrement 7*ncrement will be a""e" if "uplicate number foun" in 'atabase.:

 

'%$%4 (he software must retrie,e% up"ate% an" store "ata from multiple input

locations inclu"ing but not limite" to hospital workstations% physician workstations% inboun" emergency ,ehicles% an" electronic monitoring e)uipment. '%$%5 (he software must allow patient to ,iew their own me"ical recor" online

allowing changes only to a""ress% phone number% an" insurer after initial input. '%$%6 (he software must only allow "eletions by the ,en"or an" only after

archi,ing "ata in flat file format. 2eference ..  =ote. 'eletions will only be performe" at the re)uest of the patient or the "ece"ent6s heirs in compliance with H*&H*&-- gui"elines. p atient name. '%$%7 (he software to be "e,elope" must "isplay the correct patient '%$%$8 (he software to be "e,elope" shall "isplay the correct time of "ay in

compliance with *+ A<1. 2eference 1.?.1A '%$%$$ (he software to be "e,elope" must operate without interruption twenty/

four hours a "ay. '.$%$& (he software must allow full an" complete recor" search )ueries by

 physiciansF also allow access to limite" limite" bloo"work% me"ication% an" allergen information by EM( personnel an" "isplay results in or"er specifie" by operator. o f "iagnostic imagery an" 4-(? 4-(? '.$%$' (he software must allow input of compression for storage an" transmission of "ata.

 

'%$%$* (he software must enable out put of real/time "ata an" imagery from

electronic "iagnostic e)uipment through !a,a applets which run in the web  browser. 2efer to .1  =oteI =urses at workstation or "octors at "esktop can access this "ata. '%$%$, (he software must retrie,e an" sort me"ical recor" information an" allow

for screen an" print output of sai" information.  =ote. &rint output will inclu"e name% 'B% an" re)ueste" "iagnostic information only. '%$%$4 (he software must encrypt the "ata using 2i!n"ael 7-E+: encryption

algorithms from the "atabase for transmission from point to point.

'%& 1on2 Functiona Functionall +e0uirements of P/ysician Digital +ecord System   '%&%$ (he software interface must follow "esign con,entions which allow for

familiar location of "rop "own menus% help etc. '%&%& *nput errors will be returne" in re" with appropriate message box. '%&%' More than three attempts at login an" failure will pro"uce a re" flag to system a"ministrator. a"ministrator.

'%' P/ysician Digital +ecord System Performance +e0uirements '%'%$ (he &hysician software shoul" be able to support at least three simultaneous users. '%'%&(he &hysician software shoul" support "iagnostics inputs 7see section .1:% three terminals an" a +3 ser,er "atabase. '%'%' ;N of the transactions shall be processe" in less than one secon". '%'%* 'ata shoul" be secure" an" backe" up e,ery )uarter hour.

 

'%'%, &ower supply shoul" ha,e a back up an" a "isaster reco,ery plan. '%'%4 +ystem shoul" be operable  hours a "ay an" accessible in real/time. '%'%5 +ecure +ocket ayer ?. with 1A bit encryption will enable network security

'%* 3ogical Data#ase +e0uirements

 

4igure ?..1 &hysicians ffice Entity 2elationship 'iagram

'%, Design Constraints   '%,%$ Har"ware% software% an" "ata communication elements must be source" within bu"getary constraints.

*% Specific +e0uirements of Hospital System

 

*%$ Functional +e0uirements of Hospital Digital +ecord System *%$%$ (he software must allow input of patient "ata from the patient an" the

&hysician.  

=ote. - web/base" system can allow initial patient information to be gathere" by a "umb terminal in office or from patient6s own computer upon Email appointment ,erification hyperlinke" to input screen. *%$%& (he software must re)uest username an" passwor" for access to "ata%

only after authentication the system will allow access. *%$%' (he software must re)uire high le,els of error correction an" input

,ali"ation.  =ote. Message box prompts woul" re)uire a secon" entry of key "ata fiel"s inclu"ing name% 'B% +ocial +ecurity =umber% me"ications an" allergies. 'octor6s inputs will similarly prompt proper co"e sets for "iagnosis. *%$%* (he software must allow browsing by the physician of historical me"ical

information of his0her patients only. *%$%, (he software must i"entify the patient by a uni)ue numeric i"entifier

"eri,e" from a function performe" on the patient6s birth "ate.  =ote. -lgorithm -lgorithm will be simply ('-K ('-K/B* /B*2( 2(H'-K H'-K L =M  'octor 8ey  *ncrement 7*ncrement will be a""e" if "uplicate number foun" in 'atabase.:

 

*%$%4 (he software must retrie,e% up"ate% an" store "ata from multiple input

locations inclu"ing but not limite" to hospital workstations% physician workstations% inboun" emergency ,ehicles% an" the electronic monitoring e)uipment. *%$%5 (he software must allow patient to ,iew their own me"ical recor" online

allowing changes only to a""ress% *nsurance O an" phone number. *%$%6 (he software must only allow "eletions by the ,en"or an" only after

archi,ing "ata. 2eference .. *%$%7 (he software to be "e,elope" must "isplay the correct patient name. *%$%$8 (he software to be "e,elope" shall "isplay the correct time of "ay in

compliance with *+ A<1. 2efer to 1.?.1A *%$%$$ (he software to be "e,elope" must operate twenty/four hours a "ay. *.$%$& (he software must allow full an" complete recor" search )ueries by

 physiciansF also allow access to limite" bloo"work% me"ication% an" allergen information by EM( personnel an" "isplay results in or"er specifie" by operator. *.$%$' (he software must allow input of "iagnostic imagery an" 4-(? 4-(?

compression for storage an" transmission of "ata. *%$%$* (he software must enable out put of real/time "ata an" imagery from

electronic "iagnostic e)uipment through !a,a applets which run in the web browser.  =oteI =urses at workstation or "octors at "esktop can access this "ata.

 

*%$%$,(he software must retrie,e an" sort me"ical recor" information an"

allow for screen an" print output of sai" information.  =ote. &rint output will inclu"e name% 'B% an" re)ueste" "iagnostic information only. *%$%$4 (he software must encrypt the "ata using 2i!n"ael 7-E+: encryption

algorithms from the "atabase for transmission from point to point.

*%& 1on2 Functional +e0uirements of Hospital Digital +ecord System *%&%$ (he software interface must follow "esign con,entions which allow for

familiar location of "rop "own menus% help etc. *%&%& *nput errors will be returne" in re" with appropriate message box. *%&%' More than three attempts at login an" failure will pro"uce a re" flag to system a"ministrator. a"ministrator.

*%' Hospital Digital +ecord System Performance +e0uirements '%'%$ (he Hospital software shoul" be able to support up to ? simultaneous users. '%'%&(he Hospital software shoul" support an internet ser,er% "iagnostics inputs 7see section .1:% thirty two terminals an" a +3 ser,er "atabase. '%'%' ;N of the transactions shall be processe" in less than one secon". '%'%* 'ata shoul" be secure" an" backe" up e,ery )uarter hour. '%'%, &ower supply shoul" ha,e a back up an" a "isaster reco,ery plan. '%'%4 +ystem shoul" be operable  hours a "ay an" accessible in real/time. '%'%5 +ecure +ocket ayer ?. with 1A bit encryption will enable network security

*%* 3ogical Data#ase +e0uirements

 

  (B' *%, Design Constraints   *%,%$ Har"ware% software% an" "ata communication elements must be source" within bu"getary constraints.

,% Specific +e0uirements of +eal2time Patient Monitoring System ,%$ Functional +e0uirements of +eal2time Patient Monitoring System ,%$%$ (he software to be "e,elope" shall accept output from existing patient  monitoring e)uipment. ,%$%& (he software to be "e,elope" shall "isplay graphical an" numeric "ata at a remote location in real time. ,%$%' (he software to be "e,elope" shall graphically "isplay output from an E89 oscilloscope monitor. ,%$%* (he  software to be "e,elope" shall "isplay numeric output from an E89 monitor. ,%$%, (he software to be "e,elope" shall "isplay numeric percentages from a  pulse oximeter. ,%$%4 (he software to be "e,elope" shall "isplay numeric ,alues for systolic  bloo" pressure. ,%$%5 (he software to be "e,elope" shall "isplay numeric ,alues for "iastolic  bloo" pressure. ,%$%6 (he software to be "e,elope" shall "isplay numeric ,alues for mean bloo"

 pressure. ,%$%7 (he software to be "e,elope" shall "isplay numeric ,alues for bo"y temperature. ,%$%$8 (he software to be "e,elope" shall "isplay text ,alues for patient i"entification. ,%$%$$ (he software to be "e,elope" shall "isplay text ,alues for time of "ay.

,%& 1on2 Functional +e0uirements of +eal2time Patient Monitoring System

 

,%&%$ (he software to be "e,elope" must "isplay correct numeric pulse oximeter  ,alues at a remote location within fi,e secon"s. 7=ote. Correct ,alues within ?N of actual 1D: ,%&%& (he software to be "e,elope" must "isplay correct numeric E89 ,alues , alues at a remote location within fi,e secon"s. ,%&%' (he software to be "e,elope" must "isplay a correct graphical E89 oscilloscope wa,eform at a remote location within fi,e secon"s. ,%&%* (he software to be "e,elope" must "isplay correct numeric bloo" pressure ,alues at a remote location within fi,e secon"s.

bo "y ,%&%, (he software to be "e,elope" must "isplay correct numeric bo"y temperature ,alues at a remote location within fi,e secon"s. ,%&%4 (he software to be "e,elope" must "isplay the correct patient name. ,%&%5 (he software to be "e,elope" shall "isplay the correct time of "ay. ,%&%6 (he software to be "e,elope" must operate twenty/four hours a "ay.

,%' +eal2time Patient Monitoring System Performance +e0uirements   ,%'%$ -c)uisition of E89 'ata will re)uire soli"% wet gel% banana socket% snap or tab "isposable electro"e sensors.   ,%'%& Electro"e 7E89: sensors will attach to electronic monitoring e)uipment through ?< inch *EEE compliant uni,ersal un i,ersal lea" wires. 2efer to 2e)uirement .?.1   ,%'%' &ulse oximetry "ata must be collecte" using Masimo finger sensor.   ,%'%* Masimo finger sensor must connect to Masimo interface cable. 2efer to 2e)uirement .?.?

,%* Design Constraints   ,%*%$ 2eal/time +ensors an" 'iagnostics may nee" to be simulate" "ue to inability to access authentic healthcare e)uipment. +ec urity are life critical issues with this system.   ,%*%& 'ata *ntegrity an" +ecurity   ,%*%' 2e"un"ant power an" transmission shoul" be a""resse" as this system is life critical.

 

4% Specific +e0uirements of )m#ulatory Medical System 4%$ Functio Functional nal +e0u +e0uire iremen ments ts of )m )m#ula #ulatory tory Med Medical ical Syste System m 7=ote. -ske" source about bloo" type% allergies% etc. informe" that information presently not rele,ant to EM(. 1D: 1D: 4%'%$ (he software to be "e,elope" shall accept output from existing patient  monitoring e)uipment. 4%'%& (he software to be "e,elope" shall "isplay graphical an" numeric "ata at a remote location in real time. 4%'%' (he software to be "e,elope" shall graphically "isplay output from an E89 oscilloscope monitor. 4%'%* (he software to be "e,elope" shall "isplay numeric output from an E89 monitor. 4%'%, (he software to be "e,elope" shall "isplay numeric percentages from a  pulse oximeter. 4%'%4 (he software to be "e,elope" shall "isplay numeric ,alues for systolic  bloo" pressure. 4%'%5 (he software to be "e,elope" shall "isplay numeric ,alues for "iastolic  bloo" pressure. 4%'%6 (he software to be "e,elope" shall "isplay numeric ,alues for mean bloo"  pressure. 4%'%7 (he  software to be "e,elope" shall "isplay text ,alues for patient i"entification.

4%& 1on2 Functional +e0uirements of )m#ulatory Medical System 4%*%$ (he software to be "e,elope" must "isplay correct numeric pulse pu lse oximeter  ,alues at a remote location within fi,e secon"s. 7=ote. Correct ,alues within ?N of actual 1D:

, alues at 4%*%& (he software to be "e,elope" must "isplay correct numeric E89 ,alues a remote location within fi,e secon"s.

 

4%*%' (he software to be "e,elope" must "isplay a correct graphical E89 oscilloscope wa,eform at a remote location within fi,e secon"s. 4%*%* (he software to be "e,elope" must "isplay correct numeric bloo" pressure ,alues at a remote location within fi,e secon"s. 4%*%, (he software to be "e,elope" must operate twenty/four hours a "ay.

4%' +eal2time )m#ulatory Medical System Performance +e0uirements   (B' 4%* Design Constraints   (B'

nd of Soft.are +e0uirements Specification

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